BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE

    MDR report key: 22346026 · Received June 27, 2025

    Report

    Report Number
    8030965-2025-06532
    Event Type
    Injury
    Date Received
    June 27, 2025
    Date of Event
    March 16, 2025
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819650671
    PMA / PMN Number
    K160167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY REVIEW PART# 04.037.163S, LOT # H800122, MANUFACTURING SITE: SYNTHES USA HQ, INC, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 17 DEC 2018, EXPIRATION DATE: 01 DEC 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO A BROKEN TFNA NAIL THE NAIL WAS BROKEN AT BLADE HEIGHT. PATIENT HAD A PREVIOUS REVISION SURGERY TO REPLACE A NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974013 11MM/130 DEG TI CANN TFNA 420MM/LEFT - STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH H800122 07611819650671

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention CERCL-CABLE W/CRIMP Ø1.7| CERCL-CABLE W/CRIMP Ø1.7| CERCL-CABLE W/CRIMP Ø1.7| LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN| LOCKSCR Ø5 L40 F/NAILS TAN LIGHT GREEN| LOCKSCR Ø5 L44 F/NAILS TAN LIGHT GREEN| SYNREAM REAMING ROD ø2.5 SHORT L950| TFNA END CAP EXTENS. 0 TAN| TFNA HELICAL BLADE PERF L100 TAN